Comparison of Intravenous Injection of Calcium Antagonist and Beta-blockade on Endothelial Shear Stress of Coronary Artery
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ClinicalTrials.gov Identifier: NCT01171911 |
Recruitment Status : Unknown
Verified April 2010 by Nanjing Medical University.
Recruitment status was: Not yet recruiting
First Posted : July 29, 2010
Last Update Posted : July 29, 2010
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Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis.
The present study aims at comparing the re-distribution of shear stress and blood velocity during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome Coronary Artery Disease | Drug: Nicardipine , Esmolol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Nanjing First Hospital, Nanjing Medical University |
Study Start Date : | October 2010 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | December 2010 |

- Drug: Nicardipine , Esmolol
A loading dose of Nicardipine 10mg was at a bolus injected through vein , then continuous trans-venous titration at a speed 1ug/kg was kept. A loading dose of Esmolol 0.5mg/kg/min was at a bolus injected through vein , then continuous trans-venous titration at a speed 0.2mg/kg/min was kept.Other Name: Calcium channel blocker
- Endothelial shear stress assessed by computational fluid dynamics [ Time Frame: After four minutes ]At the peak effect of drug that the mean blood pressure (MBP) reduced by 10% or more, or the heart rate increased by 10-15 bpm.
- Minimal lumen area by intravascular ultrasound [ Time Frame: After four minutes ]At the peak effect of drug that the mean blood pressure (MBP) reduced by 10% or more, or the heart rate increased by 10-15 bpm.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of unstable angina and non-Q wave myocardial infarction
- Age 18-75 yr.
- Diameter stenosis of coronary artery<70% diameter stenosis by visual estimation
- Blood pressure >110/70 mmHg
- Heart rate 60-~100 bpm, No cardiac arrhythmias
Exclusion Criteria:
- St-elevation myocardial infarction
- Lower blood pressure(<100/70mmHg)
- Heart rate <60 or >100 bpm, The presence of cardiac arrhythmias
- Allergy to study drugs
- Women in pregnancy
- Liver dysfunction
- Creatinine >2.5mg/dl
- Bleeding stroke within 6 months
- Left ventricular ejection fraction<30% before maximal medication

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171911
Contact: Shaoliang Chen, Director | +86-25-52208048 | chmengx@126.com |
China, Jiangsu | |
Nanjing First Hospital,Nanjing Medical University | |
Nanjing, Jiangsu, China, 210006 | |
Contact: Shao-liang Chen, Director +86-25-52208048 chmengx@126.com |
Study Chair: | Shao-liang Chen, Director | Nanjing First Hospital, Nanjing Medical University |
Responsible Party: | Shao-Liang Chen/Hospital director, Nanjing First Hospital |
ClinicalTrials.gov Identifier: | NCT01171911 |
Other Study ID Numbers: |
NJESS20103079 |
First Posted: | July 29, 2010 Key Record Dates |
Last Update Posted: | July 29, 2010 |
Last Verified: | April 2010 |
Endothelial shear stress Calcium channel blocker |
Coronary Artery Disease Acute Coronary Syndrome Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Nicardipine Calcium Channel Blockers Esmolol |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Membrane Transport Modulators Vasodilator Agents |